Apparatus and method for incising

ABSTRACT

A multi-shaft apparatus for incising a substrate of soft resilient material such as a body tissue. The incising apparatus includes two or more incision shafts each having a distal edge. The shafts are not affixed to each other and are allowed to slide against each other to drive the distal edges alternately against the substrate to incise the substrate. In the case of incising a body tissue, such alternate motion would result in less pain to the patient than a puncture resulting from a sharp jab by a sharp shaft of similar size to the shafts.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of copending application Ser. No. 09/050,748filed on Mar. 30, 1998.

FIELD OF THE INVENTION

The present invention relates to techniques for incising a surface, andmore particularly to techniques for incising skin of a patient to obtaina blood sample through a tubular channel.

BACKGROUND

The analysis and quantification of blood components is an importantdiagnostic tool for better understanding the physical condition of apatient. Since adequate noninvasive blood analysis technology is notcurrently available, blood samples still need to be obtained by invasivemethods from a great number of patients every day and analyzed. A wellknown example of such needs is self-monitoring of glucose levels by adiabetic individual, e.g., performed at home. Upon doctors'recommendations and using such products, patients typically measureblood glucose level several (3-5) times a day as a way to monitor theirsuccess in controlling blood sugar levels. For many diabetics, thefailure to test blood glucose regularly may result in damage to tissuesand organs, such as kidney failure, blindness, hypertension, and otherserious complications. Nevertheless, many diabetics do not measure theirblood glucose regularly.

One important reason why patients fail to regularly take blood samplesto self-monitor physiological conditions is that the existing monitoringtechniques and products for sampling blood cause appreciable pain anddiscomfort during the sampling process. The current technique ofself-administered blood sampling involves using lancets made ofstainless steel cylindrical rods the tips of which are shaped to easepenetration into the tissue past the epidermis, into the dermis torupture the blood vessels in the dermis. Typically, the lancet ispropelled by a spring-loaded mechanism that pushes the sharp tip of thelancet into the skin. Studies on pain associated with blood samplingusing lancets that are currently commercially available indicate thatthese lancets often cause considerable pain and large tissue damage.Attempts have been made to reduce pain by reducing the size of thelancet. However, this has not been shown to reduce the amount of pain toan acceptable level for many people.

Therefore, it is desirable to devise techniques of blood extraction andmeasurement that are easy to administer. There is a need for improveddevices and methods for sampling blood that can be used with very littlepain and discomfort to the patient.

SUMMARY

In one aspect, this invention provides multiple-shaft apparatuses forincising soft resilient substrates, e.g., body tissue. In an embodiment,the apparatus includes two or more incision shafts each having a distaledge. The shafts are non-fixedly associated with one another forrelative motion to drive the distal edges against the body tissue atdifferent velocities to incise the body tissue (hereinafter “tissue”).

The main cause of pain in blood sampling is believed to be thepropagation of the pressure waves initiated by the impact of the lancettip on the tissue. All the force needed for penetration is supplied inan instant by the spring in conventional lancet driving mechanisms. Thetotal pressure on the tissue using such spring-loaded impact lancets istherefore large and consequently leads to significant pain. Amultiple-shaft proboscis having a channel through which blood can bepassed is applicable in an apparatus for drawing blood for sampling froma patient according to the present invention. The different shafts (orparts of the proboscis) cut into the tissue at different times, e.g., bya reciprocative motion as the proboscis is advanced against the tissue.This invention reduces pain associated with sampling blood via aneedle-like structure being inserted into the body tissue. Theintermittent, “stop and go” motion of the cutting edges of the proboscishelps the cutting edges to cut into the tissue as they are advanced intothe tissue. This intermittent cutting results in small penetration stepsand very small penetration pressure being applied to the tissue throughthe pushing action of the proboscis. The intermittent cutting motion ispreferably reciprocative, i.e., reciprocating, i.e., with a reverse indirection periodically. The intermittent cutting motion can also beeither longitudinal or rotational. Small pressure resulting from suchcutting motions effects extremely low stimulation to the nerve endingsat the tissue being cut for blood sampling. As a result, very littlepain is sensed by the patient in the blood sampling procedures of thepresent invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures are included to better illustrate the embodimentsof the apparatus and technique of the present invention. In thesefigures, like numerals represent like features in the several views.

FIG. 1 shows a block diagram of an embodiment of a blood samplingapparatus of the present invention.

FIG. 2A shows a sectional view of an embodiment of a proboscis of thepresent invention.

FIG. 2B shows an isometric view in portion of the proboscis of FIG. 2A.

FIGS. 2C-2D are sectional views showing the relative movement of theparts of the proboscis of FIG. 2A according to the present invention.

FIG. 3 to FIG. 5 are sectional views showing exemplary embodiments ofconcentric tubular proboscis according to the present invention.

FIG. 6 shows a graphical representation of an example of how theproboscis sections of FIG. 2 can be driven.

FIG. 7 shows an isometric view in portion of an embodiment of aproboscis for rotational cutting motion according to the presentinvention.

FIG. 8A to FIG. 8D show sectional views of embodiments in which only onetube in the proboscis has a cutting edge.

FIG. 9A shows a sectional view of an embodiment of a proboscis that issplit in halves longitudinally.

FIG. 9B shows an isometric view in portion of the proboscis of FIG. 9A.

FIG. 10 to FIG. 14 show sectional views of embodiments of a probosciscomposed of longitudinal sections forming a channel.

FIG. 15 shows a schematic sectional representation of an embodiment ofblood sampling apparatus having a driver.

FIG. 16 shows a schematic sectional representation of another embodimentof a blood sampling apparatus having a driver.

FIG. 17 shows a schematic sectional representation of a proboscisassociated with a driver having a curved PZT piece.

FIG. 18 shows a graphical view of how the proboscis of FIG. 17 can bedriven.

FIG. 19 shows a schematic sectional representation of another embodimenthaving a curved PZT piece for driving a proboscis.

FIG. 20 shows a schematic sectional representation of how a splitproboscis can be driven.

FIG. 21 shows an isometric representation of the distal portion of anembodiment of a proboscis with a split solid shaft of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

The disclosure of the copending application Ser. No. 09/050,748 isherein incorporated by reference in its entirety, including the claims.

Since that application is the parent of the present application, no newmatter is included.

In one aspect of the invention, the present invention provides anapparatus for incising a surface of a patient to obtain blood, byinserting a multi-shaft proboscis into the body tissue through itssurface to obtain a blood sample with relatively little pain. Using theproboscis apparatus, a patient can obtain a blood sample with less painthan utilizing a conventional blood sampling apparatus such as a lancetand associated device.

FIG. 1 is a block diagram illustration of an embodiment of an bloodsampling apparatus of the present invention. In FIG. 1, the bloodsampling apparatus 100 has a proboscis 102, which is driven by a driver104 to incise or cut into body tissue. A container 106, having a spacesuch as a cavity or chamber, can be connected to the proboscis in fluidcommunication for containing or storing the blood being sampled andpassed therein from the proboscis 102. Optionally, capillary action, orsuction from a vacuum-creating device, can be used to draw blood fromthe body tissue.

A. PROBOSCIS

The proboscis of the present invention is constructed to incise, or cutinto body tissue with reduced or minimal pain to the patient. As usedherein, the term “proboscis” refers to a multiple-part, elongated,needle-like structure with or without a channel wherein a fluid canflow. Such a proboscis can be used for inserting into a soft, resilientmaterial. For example the proboscis can be used to cut into a bodytissue such as skin of an individual, to rupture the skin andcapillaries below the skin to cause bleeding. If desired, the probosciscan be of a design suitable for drawing a fluid, e.g., blood, from thematerial through, for example, a channel in the proboscis. FIG. 2A andFIG. 2B illustrate an embodiment of a proboscis of the presentinvention. In this embodiment, the proboscis 110 contains two shafts112, 114, which are concentric tubes. As used herein, the tubes can beconsidered “shafts” since they are elongated and run along theproboscis. The distal end of the outer tube 112 is beveled to result ina bevel surface 116 facing outwardly away from the axis of the tube 112at an angle. The bevel surface 116 leads to a sharp ring-shaped end 118at the distal tip 120 of the proboscis 110. As is herein, the term“distal” refers to the position, direction or orientation that istowards the body tissue to be incised. The term “proximal” refers to aposition, direction or orientation opposite to that of “distal.” Thedistal end of the inner tube 114 is beveled to result in a bevel surface126 facing inwardly at an angle towards the axis of the tube 114. Thebevel surface 126 leads to a sharp ring-shaped end 128 at the tip 120 ofthe proboscis 110. The dimensions of the proboscis depend on the amountof blood needed to be drawn. Typically, e.g., in blood sampling forglucose testing self-administered by patients, the proboscis can have achannel about 100 to 2,000 microns in inside diameter, preferably about200 to 500 microns in inside diameter. The longitudinal reciprocativerelative movement between two halves can be measured in microns (e.g.,in a range of 1 to 100 microns).

FIG. 2C and FIG. 2D illustrate one way how the proboscis 110 of FIGS. 2Aand 2B incises body tissue. The outer tube 112 (or shaft) and inner tube114 (or shaft) associate with each other in close proximity with lowfriction between them so that one can slide on the other freely. In theembodiment illustrated in FIGS. 2C and 2D, the tubes 112, 114 are drivento move longitudinally reciprocatively such that alternately the sharpring-shaped end 118 of the outer tube 112 is more distal than the end128 of the inner tube 114 (as shown in FIG. 2C) and the sharpring-shaped end 128 of the inner tube 114 is more distal than the end118 of the outer tube 112 (as shown in FIG. 2D). The arrows A in FIG. 2Cshow the direction of the movement of the outer tube 112 towards thedistal end and the arrows B shows the direction of the movement of theinner tube 114 away from the distal end. Similarly, the arrows in FIG.2D show the directions of reciprocative movement in the oppositedirection as those of FIG. 2C.

In the embodiment shown in FIGS. 2A-2D, the inner tube 114 is beveledinside and the outer tube 112 is beveled outside. Such a configurationprovides a sharp circular contact by the distal tip 120 of the proboscis110 with the tissue. The static cutting angle of this proboscis 110 istwice the bevel of each edge (i.e., if the bevel angle is the same forthe inner tube and the outer tube). Since the inner tube and outer tubeare in close contact, no significant gap exists between the tubes 112and 114. This structure provides a clean cutting-edge, substantiallyeliminating the risk of tissue or blood being trapped between the tubes.

FIG. 3 shows an embodiment of a proboscis 110B in which both the outertube 112B and inner tube 114B are shaped at an angle like a hypodermicneedle. Thus, when aligned, the angled edge 118B of the outer tube 112and the angled edge 128B of the inner tube 114B are matched and form thesame angle with the axis of the tubes 112B and 114B, which areconcentric. An advantage of this structure is that both tubes can beground at once to form the angled edges 118B and 128B. This proboscis,as one skilled in the art will also understand regarding the followingembodiments, can be driven using the reciprocative action as describedabove for the embodiment of FIGS. 2A-2D.

FIG. 4 shows an embodiment of a proboscis 110C in which both the outertube 112C and inner tube 114C are beveled outwardly at the same angle.When the inner and outer tubes are correctly aligned, they can be groundtogether with the same grind step, since the bevel surface 116C of theouter tube 112C and the bevel surface 126C of the inner tube 114C facethe same direction. This structure also provides a good hold on thetissue by one tube when the other cuts or incises the tissue, therebyproviding easy penetration into the tissue as the proboscis is beinginserted into the tissue with reciprocative action.

FIG. 5 shows an embodiment of a proboscis 110D in which the outer tube112D is beveled inwardly towards the axis at an angle and inner tube114D is beveled outwardly away from the axis at an angle. The bevelsurface 116D and 126D of the tubes face generally at an angle towardseach other. This structure also provides a good hold on the tissue byone tube when the other cuts or incises the tissue. It is suited forinserting into a capillary bed to sample blood.

Although in the above the cutting devices are described as hollow tofacilitate combining the steps of cutting and channeling blood to astorage or measuring device, the cutting and the channeling steps can bedone with different devices. In that case the hollow proboscis can bereplaced with a non-hollow one, which includes component shafts thatreciprocatively move relative one another for cutting. For example, thecomponent shafts can be two halves of a solid needle, in which the twohalves slide on each other as they move reciprocatively back and forthlongitudinally. It is further contemplated that the proboscis can havetwo or more parts to form such a solid proboscis. Additionally, thesolid pieces of the proboscis can slide inside a tube, which steadiesthe pieces from lateral motion, i.e., in directions generallyperpendicular to the reciprocative movement.

Relative Motion of the Cutting Edges

To facilitate penetration of the shafts into a substrate, i.e., a softresilient material such as body tissue, e.g., skin, the shafts arepreferably driven to cut or incise the substrate at different velocity.As used herein, the term “difference in velocity” or “differentvelocity” refers to either a difference in either direction of motion ormagnitude of speed, or both among the shafts. Such a cutting processwill result in the shafts not penetrating the substrate to the samedegree simultaneously, thus reducing the pressure waves on thesubstrate. Thus, incising with the separate parts of the proboscis toinsert it into the body tissue according the present invention can bedone with reduced pain.

For illustration, FIG. 6 illustrates exemplary reciprocative relativemotion of the proboscis parts (e.g., the shafts or tubes of FIGS. 2 to5). The top tracing 132A represents the voltage of the driver thatdrives the reciprocative motion of, for example, the inner tube of aproboscis, and the bottom tracing 132B represents the voltage of thedriver that drives the reciprocative motion of, for example, the outertube of the same proboscis. At the lower voltage V_(O) the tube isstationary and at the higher voltage V₁ the tube is driven to cut intothe tissue. The incising process can be initiated by pressing thecutting edges of the proboscis against the tissue to be penetrated witha minimal force. One of the cutting edges is then pushed towards thetissue with a small differential force while the other edge is anchoringthe tissue. After the moving edge has penetrated into the tissue to apredetermined differential depth, that edge is arrested and it in turnbecomes the anchoring edge as the other edge is moved with adifferential force. The other edge is moved until it penetrates into thetissue to a predetermined differential depth. The whole process isrepeated, with the two cutting edges moving alternately in reciprocativemotion. Although the present invention is not limited by any scientifictheory, it is believed that pain is reduced as the proboscis is insertedinto a patient because the noncontinuous incising process employed inthe present invention cuts the tissue in small amounts in a step byapplying minimal pressure to the tissue for cutting. It has been shownthat the application of reciprocating cutting device reduces the totalforce required to penetrate a tissue-like material. This reciprocativeprocess reduces the tendency of the cutting edge being bound by frictionto the tissue being cut. Thus, in the present invention, thereciprocative motion of the parts of the proboscis reduces the totalforce transmitted to the tissue and hence reduces the pain associatedwith cutting. Further, since the two cutting edges do not move at thesame time, one cutting edge stabilizes the tissue while the othercutting edge cuts, thereby reducing the pushing and pulling forcestransferred to the tissue and hence to the nerves. The reduction ofpushing and pulling forces on the nerves results in less pain to thepatient. In using the cutting device of the present invention, typicallythe cutting time is in the range of about 0.1 to 5 seconds, preferablyabout 0.5 to 1 second. In this way the sharp pain associated with thesudden jab as done in the convention incising methods is reduced.

One skilled in the art will be able to vary the above describedprocedure in a variety of ways. For example, the distance, speed, andtiming of the reciprocative motion can be varied. Another example isillustrated in FIG. 7, in which the reciprocative relative motion of theinner tube and outer tube of a structure similar to that of FIG. 2 isrotational instead of longitudinal. When rotation is used to cut thetissue, preferably, one of the tubes is held static while the otherrotates, resulting in a shearing action for cutting the tissue withoutapplying a substantial impact force. Thus, one cutting edge cuts thetissue by a curving, slicing motion of the cutting edge while the othercutting edge stationarily anchors the tissue and vice versa as theprocess is reversed so the tubes alternately cut into the tissue. Such areduced impact cutting method considerably reduces the pressure waves,which are associated with pain, transmitted to the tissue. As anotherexemplary alternative, instead of driving the tubes to move in oppositedirections, the tubes can be driven to move in the same direction. Also,instead of driving each tube to move back and forth, the same tube canbe driven to move always in the same direction. In the case the tubesmove in opposite directions, the tubes can be driven to movesimultaneously as well.

In the above described embodiments, both of the proboscis parts (whichinclude cutting edges) are moved to cut into the tissue as the proboscisis urged into the tissue. However, embodiments of proboscis can be usedin which only one of the proboscis parts is moved for cutting. FIGS. 8Ato 8D illustrate exemplary embodiments of such a proboscis. One of thetubes can have a blunt distal edge 134, or 134B for holding on to thetissue as the other edge 128E, 128F, 128G, or 128H moves.

Generally, the distance of travel of a proboscis part for eachreciprocative (or regular intermittent) movement is selected to reducethe pressure wave on the skin so as to reduce the pain associated withsampling blood. Although the present invention is not limited to anyspecific values, typically, the distance of travel of a shaft in eachreciprocative movement for a proboscis section is about 0.001 mm to 0.5mm, preferably about 0.01 mm to 0.1 mm. The frequency of reciprocative(or regular intermittent) movement is typically about 0.1 KHz to 100KHz, preferably about 10 KHz to 75 KHz.

Split Proboscis

As an alternative to using concentric tubes for reciprocative cutting,one can use a proboscis that contains parts that match with one anotherto form a channel through which fluid can flow. Thus, a tube is splitinto two or more longitudinal sections (i.e., pieces), which can beconsidered as shafts, each of which sections reciprocates with respectto the other. FIGS. 9 to 14 illustrates exemplary embodiments ofproboscis in which two or more pieces join to form a channel. Thecutting edges of the proboscis sections may be prepared in variouscombinations of those shown in the above-described embodiments for theconcentric tubes. Furthermore, one of the split sections can bestructured for anchoring and the other can be structured with a cuttingedge for cutting. FIGS. 9A and 9B illustrates an embodiment of aproboscis 110K, with two longitudinal halves 142K, 144K each with asemicircular cross-section, in the form of a cylindrical capillary tubeas a whole. The distal end of each of the halves 142K, 144K is beveledto result in a distal sharp cutting edge. FIG. 10 shows a splitproboscis embodiment with two halves 142L and 144L forming a proboscis110L with a square cross section.

Various ways can be used to split the proboscis to result in a channelof a particular shape. For example, for a square channel, the probosciscan be split in, e.g., the ways illustrated in FIGS. 10 to 13. In thesefigures, the proboscis 110L-110P are composed of sections 142L-142P andsections 144L-144P respectively for the different embodiments.Similarly, for a proboscis embodiment 110Q with a channel having atriangular cross-section and composed of sections 142Q and 144Q (forexample, as shown in FIG. 14), the sections can be structured withsections having many different shapes.

B. DRIVING MECHANISM

The proboscis sections of the present invention can be drivenreciprocatively by a variety of mechanisms, including, e.g.,electromagnetic, electrostatic, pneumatic, hydraulic, and piezoelectricmechanisms. For illustrative purposes, exemplary embodiments ofpiezoelectric mechanisms for driving proboscis sections are describedbelow.

FIG. 15 shows such an embodiment that is suitable for producingreciprocative motion of the concentric tubes as those described above.The blood sampling apparatus 146 includes proboscis 110 and driver 147.Although one skilled in the art will understand how a suction or storagemechanism can be connected to such an apparatus, no separate suction orstorage mechanism is shown in the figure for the sake of clarity. In thedriver 147, a first piezoelectric (PZT) device 148 when activated willtransfer oscillating motion by means of transfer support 150 to theinner tube 114 of the proboscis 110. The first PZT device 148 iscontrolled by the first power supply 152. Similarly, a second PZT device154, controlled by second power supply 158, transfers oscillating motionby means of second transfer support 156 to the outer tube 112 of theproboscis 110. A damper 160 may be used to prevent inter-PZT-devicetransfer of oscillation. Thus, each PZT device can move and slide inclose proximity relative the other without transferring its motion tothe other. The power supplies 152 and 158 may be coordinated to resultin cyclical, orchestrated motion, for example, as done in FIG. 6.Furthermore, the power supplies can be controlled to varying thevelocity of reciprocative motion of the proboscis sections.

FIG. 16 shows an illustrative embodiment of a blood sampling apparatusin which only one tube is moved reciprocatively while the other staysstatic. As in the apparatus shown in FIG. 15, the PZT device 148B drivesthe reciprocative motion of the inner tube 114 by transferring theoscillatory forces through the transfer support 150B, whereas the outertube 112 is static. A damper 160B prevents the transfer of oscillatorymotion from the PZT device L48B to the structures, such as support 156B,that are rigidly connected to the outer tube. A power supply 152Bprovides the power for activating the PZT device 148B to produce theoscillating motion.

Another method for generating the reciprocative movement is by usingcurved pieces of piezoelectric material (PZT). For example, in a curvedpiece 154 of PZT as shown in FIG. 17, the magnitude of vibrationincreases towards the center of the curved piece. Thus, the tube 156vibrates with a larger magnitude of motion if it is more towards thecenter of the curve than if it is more on the edge. In this embodiment,the DC (direct current) component of the voltage of the power supplythat drives the PZT is slowly ramped up with time (as shown in FIG. 18),causing progressive forward movement of the cutting edge into thetissue, while the AC (alternate current) component causes reciprocativemotion for cutting into the tissue. This structure can be used fordriving a tube in a proboscis with only one reciprocating tube, e.g., asthose described in the above. This mechanism, although suitable fordriving a single needle or hollow shaft, can be adapted to drive two ormore sections of a proboscis.

FIG. 19 shows an embodiment of a curved PZT device which can drive thereciprocative motion of two concentric tubes. The difference in themovement in the longitudinal direction between the two positions 158 and160 (which are connected respectively to the inner tube 164 and theouter tube 162) on the curved PZT translates into reciprocative relativemotion between the inner tube 164 and the outer tube 162. The voltagesapplied can be adjusted to control the magnitude of the relativereciprocative motion between the tubes 162 and 164.

In FIG. 20, an embodiment is shown- in which two flat PZT pieces 176,178 are activated out of phase to generate reciprocative movement in aproboscis 168 composed of two longitudinal sections 172, 174. The arrows180A and 180B shows the direction of movement at a particular instant.The same method generating reciprocative movement can be applied toother embodiments of split proboscis design.

FIG. 21 shows an illustration of a proboscis with a non-hollow, i.e.,solid, shaft, which is suitable for creating a puncture hole in asubstrate, such as body tissue such as skin, or other soft and resilientmaterials. In the embodiment of FIG. 21, the reciprocatively movingparts consists of two halves 184A, 184B of a needle 186. A tube 188encircles the portion of the needle away from the distal portion 189 ofthe needle 186. The tube 188 allows the needle halves 184A 184B to slidein it and functions to steady the needle halves as they reciprocativelymove distally and alternately and slide against each another.

The use of PZT in piezoelectric driving of a proboscis allows themeasurement of the mechanical load—measuring the electrical impedance ofthe PZT drivers. This measurement permits a feedback mechanism tocontrol the mechanical load. The mechanical load can thus be controlledand varied to minimize pain, enhance cutting speed, and control thetotal penetration depth, or even to stimulate the blood flow through thechannel for blood sampling.

Mechanisms for electromechanically, electromagnetically, fluidically,and electrostatically driving reciprocative motion are known in the art.Based on the present disclosure, these mechanisms can be-.adapted todrive the reciprocative motion of the proboscis sections. Furthermore,the driving mechanism can be controlled such that it stops, or reverseswhen a certain depth of penetration is reached. For example, animpedance sensor can be used to sense the change in electrical impedanceto determine whether the capillary bed has been reached, as described ina copending application(Attorney Docket Number 10971003-1, Inventors:Paul Lum, et al., entitled “APPARATUS AND METHOD FOR PENETRATION WITHSHAFT HAVING A SENSOR FOR SENSING PENETRATION DEPTH”) submitted on thesame day and assigned to the same assignee as the present application.This copending application also discloses mechanisms for driving a sharpobject such as a lancet. Said copending application is incorporated byreference in its entirety herein.

Although the preferred embodiment of the present invention has beendescribed and illustrated in detail, it is to be understood that aperson skilled in the art can make modifications within the scope of theinvention. For example, a multiple part proboscis according to thepresent invention may be constructed to be inserted into tissues otherthan skin, for infusion of fluid rather than withdrawal of fluid in achannel, or for introducing another piece through the proboscis, as in acatheter. In fact, a proboscis according to the present invention can beconstructed and inserted into a non-body-tissue material with reducedpressure waves during penetration of the proboscis. Also, amultiple-part pin without a channel can be made for insertion withreduced pain, e.g., for introduction of electrical current, or simplyfor mechanical stimulation as in acupuncture.

What is claimed is:
 1. A method for incising a soft resilient substrate,comprising: driving at least two or more parallel incision shafts sothat the at least one shaft moves periodically relative to another ofthe incision shafts in translational position or rotational position,the incision shafts each having a distal end; urging the shafts in adirection parallel to the shafts toward the soft resilient substratesuch that the distal ends of the shafts are driven into the softresilient substrate to result in a hole.
 2. A method according to claim1 wherein the shafts are associated with one another in an apparatus andthe method comprises steadying the apparatus against the substrate withone shaft and driving at least one of the other shafts to move relativeto the steadying shaft to incise the substrate.
 3. A method according toclaim 1 comprising sliding the shafts against each other and associatingthe shafts to include a channel for liquid flow.
 4. A method accordingto claim 1 comprising moving each of the shafts intermittently innoncontinuous motion.
 5. A method according to claim 1 wherein the edgesof the shafts are beveled each to form a sharp edge with a bevel surfaceand comprising arranging the neighboring bevel surfaces of two shafts toface away from each other.
 6. A method according to claim 1 wherein theedges are beveled to each form a sharp edge with a bevel surface andcomprising aligning the shafts such that the the neighboring bevelsurfaces of two shafts face the same direction.
 7. A method according toclaim 1 comprising moving at least one of the shafts in translationalposition relative to the other in reciprocating longitudinal action. 8.A method according to claim 7 further comprising moving two of theshafts each in reciprocating longitudinal action so that the shafts moverelative in translational position to the other.
 9. A method accordingto claim 1 wherein two shafts are concentric tubes suitable forconducting fluid and comprising moving at least one of the concentrictubes in concentric rotational motion relative to the other tube.
 10. Amethod according to claim 9 comprising moving at least one of the shaftsin intermittent reciprocative concentric rotational motion relative tothe other.
 11. A method according to claim 9 comprising moving at leastone of the shafts in intermittent concentric rotational motion relativeto the other in one direction.
 12. A method according to claim 1comprising arranging the shafts to associate with each other to form atubular channel suitable for conducting fluid and moving one shaftrelative to the other in reciprocating longitudinal action.
 13. A methodaccording to claim 1 further comprising piezoelectrically driving therelative motion of the shafts.
 14. A method according to claim 1 furthercomprising associating the shafts to form a needle-sized proboscis. 15.A method according to claim 1 wherein the at least one of the incisionshafts has a sharp edge and is periodically driven to incise the softresilient substrate while another of the parallel incision shaftsanchors itself against the soft resilient substrate.
 16. A methodaccording to claim 1 comprising driving at least one shaft in periodicreciprocative movement of from 0.001 mm to 0.5 mm and comprising urgingtwo or more shafts having sharp edges at the distal ends thereof againstthe soft resilient substrate.
 17. A method for incising a soft resilientsubstrate, comprising: (A) using a power source to drive at least two ormore parallel shafts such that one shaft moves oscillatorily relative toanother of the shafts in translational position, the shafts each havinga sharp edge at a distal end, the shafts associate as a unit to have acircular circumferencial cross-section; and (B) urging the shafts in alongitudinal direction parallel to the shafts toward a soft resilientsubstrate such that the sharp edges of the shafts are drivenlongitudinally against the soft resilient substrate to penetrate thesoft resilient substrate to result in a hole, wherein periodically theat least one of the shafts penetrates into the soft resilient substrateahead further of the another of the parallel shafts.
 18. A methodaccording to claim 17 further comprising associating the shafts to forma needle-sized proboscis having a channel therein for conducting liquidand driving at least one shaft in reciprocative movement of from 0.001mm to 0.5 mm and comprising urging two or more shafts having sharp edgesat the distal ends thereof against the soft resilient substrate.
 19. Amethod according to claim 17 wherein the shafts are tubular and furthercomprising associating the shafts concentrically such that fluid can beconducted in the tubes as a whole.
 20. A method according to claim 17wherein the shafts are needle-size and further comprising associatingthe shafts as a unit to have a circular circumferential crosssection.